Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries (TOBA II BTK)

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ClinicalTrials.gov Identifier: NCT02942966

Recruitment Status : Completed

First Posted : October 24, 2016

Results First Posted : July 28, 2021

Last Update Posted : January 31, 2022

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Sponsor:

Information provided by (Responsible Party):

Philips Clinical & Medical Affairs Global

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Peripheral Arterial Disease
Intervention	Device: Tack Endovascular System
Enrollment	233

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Tack Endovascular System (4F)
Arm/Group Description	Use of the Tack Endovascular System...
Arm/Group Description	Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
Period Title: Overall Study
Started	233 ^[1]
Completed	205 ^[2]
Not Completed	28
[1] Intent to Treat (ITT) population. [2] Completed 6-month follow-up

Baseline Characteristics

Arm/Group Title		Tack Endovascular System (4F)
Arm/Group Description		Use of the Tack Endovascular System...
Arm/Group Description		Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
Overall Number of Baseline Participants		233
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	233 participants
		74.4 (10)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	233 participants
	Female	76 32.6%
	Male	157 67.4%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	233 participants
	American Indian or Alaska Native	1 0.4%
	Asian	3 1.3%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	39 16.7%
	White	187 80.3%
	More than one race	0 0.0%
	Unknown or Not Reported	3 1.3%
BMI ^[1] Mean (Standard Deviation) Unit of measure: Kg/m^2
	Number Analyzed	231 participants
		28.8 (5.6)
		[1] Measure Analysis Population Description: BMI is missing for two subjects.
BMI >= 30 ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	231 participants
		86 37.2%
		[1] Measure Analysis Population Description: BMI is missing for two subjects.
ABI in treated limb ^[1] [2] Mean (Standard Deviation) Unit of measure: Ratio
	Number Analyzed	198 participants
		0.74 (0.27)
		[1] Measure Description: The ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery in the arm. [2] Measure Analysis Population Description: ABI information is missing for some subjects. Values ≥1.3 are censored as non-compressible.
TBI in treated limb ^[1] [2] Mean (Standard Deviation) Unit of measure: Ratio
	Number Analyzed	117 participants
		0.43 (0.23)
		[1] Measure Description: The ratio of systolic blood pressure measured at the toe to systolic blood pressure measured at the brachial artery. [2] Measure Analysis Population Description: TBI information is missing for some subjects
Rutherford Classification ^[1] Measure Type: Count of Participants Unit of measure: Participants
0	Number Analyzed	233 participants
0		0 0.0%
1	Number Analyzed	233 participants
1		0 0.0%
2	Number Analyzed	233 participants
2		0 0.0%
3	Number Analyzed	233 participants
3		38 16.3%
4	Number Analyzed	233 participants
4		78 33.5%
5	Number Analyzed	233 participants
5		117 50.2%
6	Number Analyzed	233 participants
6		0 0.0%
		[1] Measure Description: Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss. Class Clinical Description 0 Asymptomatic -no hemodynamically significant occlusive disease Mild claudication Moderate claudication Severe claudication Ischemic rest pain Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia Major tissue loss-extending above TM level, functional foot no longer salvageable
Wound Grade ^[1] Measure Type: Count of Participants Unit of measure: Participants
0	Number Analyzed	233 participants
0		122 52.4%
1	Number Analyzed	233 participants
1		91 39.1%
modified 2	Number Analyzed	233 participants
modified 2		20 8.6%
2	Number Analyzed	233 participants
2		0 0.0%
3	Number Analyzed	233 participants
3		0 0.0%
		[1] Measure Description: Part of the WIfI Classification grading system created by the Society of Vascular Surgery (SVS). This system focuses on the three main factors that impact amputation risk and clinical management: Wound, Ischemia, and foot Infection (WIfI). Each of the three factors are graded on a scale from 0 to 3. The 0 represents none, 1-mild, 2-moderate and 3-severe. For the purpose of this study only, an additional Wound grade of modified 2 was added which permits some additional wounds to be included.
Ischemia Grade ^[1] [2] Measure Type: Count of Participants Unit of measure: Participants
0	Number Analyzed	221 participants
0		115 52.0%
1	Number Analyzed	221 participants
1		55 24.9%
2	Number Analyzed	221 participants
2		28 12.7%
3	Number Analyzed	221 participants
3		23 10.4%
		[1] Measure Description: Part of the WIfI Classification grading system created by the Society of Vascular Surgery (SVS). This system focuses on the three main factors that impact amputation risk and clinical management: Wound, Ischemia, and foot Infection (WIfI). Each of the three factors are graded on a scale from 0 to 3. The 0 represents none, 1-mild, 2-moderate and 3-severe. [2] Measure Analysis Population Description: Ischemia grade missing for some subjects
Foot Infection Grade ^[1] Measure Type: Count of Participants Unit of measure: Participants
0	Number Analyzed	233 participants
0		194 83.3%
1	Number Analyzed	233 participants
1		39 16.7%
2	Number Analyzed	233 participants
2		0 0.0%
3	Number Analyzed	233 participants
3		0 0.0%
		[1] Measure Description: Part of the WIfI Classification grading system created by the Society of Vascular Surgery (SVS). This system focuses on the three main factors that impact amputation risk and clinical management: Wound, Ischemia, and foot Infection (WIfI). Each of the three factors are graded on a scale from 0 to 3. The 0 represents none, 1-mild, 2-moderate and 3-severe.

Outcome Measures

1.Primary Outcome


Title	Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days
Description	Freedom from major adverse limb events (MALE) at 6 months defined as a...
Description	Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

The number of evaluable subjects for the 6 Month Primacy Efficacy Endpoint was 209.


Arm/Group Title	Tack Endovascular System (4F)
Arm/Group Description:	Use of the Tack Endovascular System...
Arm/Group Description:	Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
Overall Number of Participants Analyzed	209
Measure Type: Count of Participants Unit of Measure: Participants
	200 95.7%

2.Primary Outcome


Title	Safety - Number of Participants With MALE Plus POD at 30 Days
Description	Major adverse limb events (MALE) at 30 days defined as above-ankle tar...
Description	Major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death at 30 days
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

Four subjects were not evaluable for the 30 Day primary safety endpoint due to missing the 30 day visit and no additional visits occurred beyond day 30. One subject was not evaluable for the 30 Day primary safety endpoint due to an early 30 day visit and no additional visits Day 30. These subjects were therefore not included in the denominator for the primary safety endpoint analysis.


Arm/Group Title	Tack Endovascular System (4F)
Arm/Group Description:	Use of the Tack Endovascular System...
Arm/Group Description:	Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
Overall Number of Participants Analyzed	228
Measure Type: Count of Participants Unit of Measure: Participants
	3 1.3%

3.Secondary Outcome


Title	Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months
Description	Target lesion(s) tacked segment(s) patency at 6 months defined as the ...
Description	Target lesion(s) tacked segment(s) patency at 6 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 6 month follow-up visit window, it should be used in place of the duplex ultrasound. Evidence of no blood flow within the Tacked segment indicates restenosis/loss of patency.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Some subjects had Tack implants placed in multiple lesions


Arm/Group Title	Tack Endovascular System (4F)
Arm/Group Description:	Use of the Tack Endovascular System...
Arm/Group Description:	Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
Overall Number of Participants Analyzed	233
Overall Number of Units Analyzed Type of Units Analyzed: Number of lesions	303
Measure Type: Number Unit of Measure: number of lesions
	248

4.Secondary Outcome


Title	Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months
Description	Target Limb Salvage defined as freedom from any above-ankle target lim...
Description	Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

The number of evaluable subjects for Target Limb Salvage at 6 Months was 209.


Arm/Group Title	Tack Endovascular System (4F)
Arm/Group Description:	Use of the Tack Endovascular System...
Arm/Group Description:	Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
Overall Number of Participants Analyzed	209
Measure Type: Count of Participants Unit of Measure: Participants
	206 98.6%

Adverse Events

Time Frame	Summary of adverse events that have been reported through 210 days
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Tack Endovascular System (4F)
Arm/Group Description	Use of the Tack Endovascular System...
Arm/Group Description	Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
All-Cause Mortality
	Tack Endovascular System (4F)
	Affected / at Risk (%)
Total	63/233 (27.04%)
Serious Adverse Events Serious Adverse Events
	Tack Endovascular System (4F)
	Affected / at Risk (%)	# Events
Total	179/233 (76.82%)
Blood and lymphatic system disorders
Anemia ^†	4/233 (1.72%)	4
Microcytic anemia ^†	1/233 (0.43%)	1
Cardiac disorders
Acute on chronic heart failure ^†	2/233 (0.86%)	3
Angina at rest ^†	1/233 (0.43%)	1
Angina pectoris ^†	1/233 (0.43%)	1
Aortic valve stenosis ^†	2/233 (0.86%)	2
Atrial fibrillation ^†	1/233 (0.43%)	1
Bradycardia ^†	1/233 (0.43%)	2
Cardiac failure aggravated ^†	1/233 (0.43%)	1
Cardiomyopathy ^†	1/233 (0.43%)	1
Congestive heart failure ^†	2/233 (0.86%)	2
Coronary artery disease ^†	1/233 (0.43%)	1
Coronary artery stenosis ^†	1/233 (0.43%)	1
Coronary heart disease ^†	1/233 (0.43%)	1
Decompensated heart failure ^†	1/233 (0.43%)	1
Decompensation cardiac ^†	3/233 (1.29%)	3
Heart failure ^†	2/233 (0.86%)	2
Heart failure NYHA class III ^†	1/233 (0.43%)	1
Heart insufficiency ^†	2/233 (0.86%)	2
Myocardial infarction ^†	2/233 (0.86%)	2
New onset angina pectoris ^†	1/233 (0.43%)	1
Non ST segment elevation myocardial infarction ^†	3/233 (1.29%)	3
Paroxysmal atrial fibrillation ^†	1/233 (0.43%)	1
Progressive angina ^†	1/233 (0.43%)	1
Right coronary artery stenosis ^†	1/233 (0.43%)	1
ST segment elevation myocardial infarction ^†	1/233 (0.43%)	1
Supraventricular tachycardia ^†	1/233 (0.43%)	1
Ear and labyrinth disorders
Supraventricular tachycardia ^†	1/233 (0.43%)	1
Gastrointestinal disorders
Abdominal pain ^†	1/233 (0.43%)	2
Coprostasis ^†	1/233 (0.43%)	1
Duodenal ulcer hemorrhage ^†	1/233 (0.43%)	1
Gastrointestinal bleed ^†	1/233 (0.43%)	1
Melena ^†	1/233 (0.43%)	1
Nausea ^†	1/233 (0.43%)	1
Oral hemorrhage ^†	1/233 (0.43%)	1
Retroperitoneal hematoma ^†	1/233 (0.43%)	1
Small bowel obstruction ^†	1/233 (0.43%)	1
Ventral hernia ^†	1/233 (0.43%)	1
General disorders
Acute chest pain ^†	1/233 (0.43%)	1
Chest pain ^†	2/233 (0.86%)	2
Delayed healing of wound ^†	2/233 (0.86%)	2
In-stent peripheral artery restenosis ^†	3/233 (1.29%)	3
Opiate withdrawal symptoms ^†	1/233 (0.43%)	1
Puncture site bleeding ^†	1/233 (0.43%)	1
Sudden cardiac death ^†	1/233 (0.43%)	1
Unknown cause of death ^†	1/233 (0.43%)	1
Hepatobiliary disorders
Acute cholecystitis ^†	1/233 (0.43%)	1
Infections and infestations
Bacteremia ^†	1/233 (0.43%)	1
Bacteriuria ^†	1/233 (0.43%)	1
Cellulitis of toe ^†	1/233 (0.43%)	1
Clostridial gastroenteritis ^†	1/233 (0.43%)	1
Erysipelas ^†	1/233 (0.43%)	1
Gangrene ^†	1/233 (0.43%)	2
Gangrene peripheral ^†	2/233 (0.86%)	4
Gangrene toe ^†	5/233 (2.15%)	6
Infection of amputation stump ^†	1/233 (0.43%)	1
Osteomyelitis of the foot ^†	4/233 (1.72%)	5
Phlegmon ^†	1/233 (0.43%)	1
Pneumonia, organism unspecified ^†	4/233 (1.72%)	5
Postoperative infection ^†	1/233 (0.43%)	1
Sepsis ^†	2/233 (0.86%)	2
Soft tissue infection ^†	1/233 (0.43%)	1
Spondylodiscitis ^†	1/233 (0.43%)	2
Staphylococcus aureus bacteremia ^†	1/233 (0.43%)	1
Urinary tract infection, site not specified ^†	1/233 (0.43%)	1
Wet gangrene ^†	1/233 (0.43%)	1
Injury, poisoning and procedural complications
Abdominal wall wound ^†	1/233 (0.43%)	1
Chronic subdural hematoma ^†	1/233 (0.43%)	1
Femoral artery pseudoaneurysm ^†	1/233 (0.43%)	1
Fracture femur ^†	1/233 (0.43%)	1
Fracture of neck of femur ^†	1/233 (0.43%)	1
Overdose NOS ^†	1/233 (0.43%)	1
Peripheral arterial reocclusion ^†	4/233 (1.72%)	6
Peripheral artery restenosis ^†	4/233 (1.72%)	4
Pseudoaneurysm ^†	2/233 (0.86%)	2
Skin tear ^†	2/233 (0.86%)	2
Traumatic brain injury ^†	1/233 (0.43%)	1
Vascular access site bleeding ^†	1/233 (0.43%)	1
Wound ^†	1/233 (0.43%)	2
Wound bleeding ^†	1/233 (0.43%)	1
Metabolism and nutrition disorders
Gout aggravated ^†	1/233 (0.43%)	1
Hyperglycemia ^†	3/233 (1.29%)	3
Hyperkalemia ^†	1/233 (0.43%)	1
Hypokalemia ^†	1/233 (0.43%)	1
Hyponatremia ^†	1/233 (0.43%)	4
Type II diabetes mellitus inadequate control ^†	1/233 (0.43%)	1
Musculoskeletal and connective tissue disorders
Coxarthrosis ^†	1/233 (0.43%)	1
Hyperuricemic arthritis ^†	1/233 (0.43%)	1
Leg pain ^†	1/233 (0.43%)	1
Polyarthritis ^†	1/233 (0.43%)	1
Prepatellar bursitis ^†	1/233 (0.43%)	1
Soft tissue disorder ^†	1/233 (0.43%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basalioma ^†	1/233 (0.43%)	1
Diffuse large B-cell lymphoma recurrent ^†	1/233 (0.43%)	1
Leukemia ^†	1/233 (0.43%)	1
Liver carcinoma ^†	1/233 (0.43%)	1
Ovarian granulosa cell tumor ^†	1/233 (0.43%)	1
Nervous system disorders
Ataxia ^†	1/233 (0.43%)	1
Bleeding intracranial ^†	1/233 (0.43%)	1
Carotid artery stenosis ^†	2/233 (0.86%)	2
Dizziness ^†	1/233 (0.43%)	1
Drop attacks ^†	1/233 (0.43%)	1
Focal epilepsy ^†	1/233 (0.43%)	1
Stroke ^†	2/233 (0.86%)	2
Syncopal attack ^†	1/233 (0.43%)	1
TIA ^†	1/233 (0.43%)	1
Transient ischemic attack ^†	1/233 (0.43%)	1
Psychiatric disorders
Confusion ^†	1/233 (0.43%)	1
Hyperactive delirium ^†	1/233 (0.43%)	1
Transient psychosis ^†	1/233 (0.43%)	1
Renal and urinary disorders
Acute kidney injury ^†	3/233 (1.29%)	3
Acute on chronic renal failure ^†	2/233 (0.86%)	2
Acute renal failure ^†	4/233 (1.72%)	4
Renal failure ^†	1/233 (0.43%)	1
Reproductive system and breast disorders
Metrorrhagia ^†	1/233 (0.43%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure ^†	1/233 (0.43%)	1
Bilateral pleural effusion ^†	2/233 (0.86%)	2
Dyspnea ^†	1/233 (0.43%)	1
Hypoxia ^†	1/233 (0.43%)	1
Lung edema ^†	1/233 (0.43%)	1
Shortness of breath ^†	1/233 (0.43%)	1
Skin and subcutaneous tissue disorders
Chronic leg ulcer ^†	1/233 (0.43%)	1
Diabetic foot ^†	1/233 (0.43%)	2
Digital ulcer ^†	2/233 (0.86%)	2
Rash ^†	1/233 (0.43%)	1
Ulcer foot ^†	1/233 (0.43%)	1
Venous ulceration ^†	1/233 (0.43%)	1
Surgical and medical procedures
Medical device battery replacement ^†	1/233 (0.43%)	1
Vascular disorders
Abdominal aortic aneurysm ^†	1/233 (0.43%)	1
Acute limb ischemia ^†	2/233 (0.86%)	2
Anterior tibial artery perforation ^†	1/233 (0.43%)	1
Arterial occlusion ^†	1/233 (0.43%)	1
Arterial stenosis ^†	1/233 (0.43%)	1
Atherosclerosis of arteries of the extremities ^†	1/233 (0.43%)	1
Claudication ^†	8/233 (3.43%)	10
Critical limb ischemia ^†	3/233 (1.29%)	3
Digital necrosis ^†	1/233 (0.43%)	1
Dry gangrene foot ^†	1/233 (0.43%)	2
Dry gangrene toe ^†	1/233 (0.43%)	1
Extremity necrosis ^†	1/233 (0.43%)	1
Hematoma ^†	1/233 (0.43%)	1
Hypertension ^†	1/233 (0.43%)	1
Hypotension ^†	3/233 (1.29%)	3
Iliac artery stenosis ^†	1/233 (0.43%)	1
Internal hemorrhage ^†	1/233 (0.43%)	1
Ischemic limb pain ^†	1/233 (0.43%)	1
Peripheral arterial occlusive disease ^†	1/233 (0.43%)	1
Peripheral arterial occlusive disease Fontaine stage IV ^†	1/233 (0.43%)	1
Peripheral arterial occlusive disease aggravated ^†	4/233 (1.72%)	5
Peripheral artery occlusion ^†	1/233 (0.43%)	1
Peripheral artery thrombosis ^†	1/233 (0.43%)	1
Peripheral vascular disease ^†	9/233 (3.86%)	10
Peripheral vascular disease ^†	1/233 (0.43%)	1
Superficial femoral arterial stenosis ^†	1/233 (0.43%)	1
Superficial femoral artery occlusion ^†	1/233 (0.43%)	1
Uncontrolled hypertension ^†	1/233 (0.43%)	1
Varicose vein ^†	1/233 (0.43%)	1
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Tack Endovascular System (4F)
	Affected / at Risk (%)	# Events
Total	137/233 (58.80%)
Blood and lymphatic system disorders
Anemia ^†	4/233 (1.72%)	4
Microcytic anemia ^†	1/233 (0.43%)	1
Cardiac disorders
Acute on chronic heart failure ^†	2/233 (0.86%)	3
Angina at rest ^†	1/233 (0.43%)	1
Angina pectoris ^†	1/233 (0.43%)	1
Aortic valve stenosis ^†	2/233 (0.86%)	2
Atrial fibrillation ^†	1/233 (0.43%)	1
Bradycardia ^†	1/233 (0.43%)	2
Cardiac failure aggravated ^†	1/233 (0.43%)	1
Congestive heart failure ^†	2/233 (0.86%)	2
Coronary artery disease ^†	1/233 (0.43%)	1
Coronary artery stenosis ^†	1/233 (0.43%)	1
Coronary heart disease ^†	1/233 (0.43%)	1
Decompensated heart failure ^†	1/233 (0.43%)	1
Decompensation cardiac ^†	3/233 (1.29%)	3
Heart failure ^†	2/233 (0.86%)	2
Heart failure NYHA class III ^†	1/233 (0.43%)	1
Heart insufficiency ^†	2/233 (0.86%)	2
Ischaemic heart disease ^†	1/233 (0.43%)	1
Myocardial infarction ^†	2/233 (0.86%)	2
New onset angina pectoris ^†	1/233 (0.43%)	1
Non ST segment elevation myocardial infarction ^†	3/233 (1.29%)	3
Paroxysmal atrial fibrillation ^†	1/233 (0.43%)	1
Progressive angina ^†	1/233 (0.43%)	1
Right coronary artery stenosis ^†	1/233 (0.43%)	1
ST segment elevation myocardial infarction ^†	1/233 (0.43%)	1
Supraventricular tachycardia ^†	1/233 (0.43%)	1
Ear and labyrinth disorders
Meniere's disease aggravated ^†	1/233 (0.43%)	1
Gastrointestinal disorders
Abdominal pain ^†	1/233 (0.43%)	2
Coprostasis ^†	1/233 (0.43%)	1
Duodenal ulcer hemorrhage ^†	1/233 (0.43%)	1
Gastrointestinal bleed ^†	1/233 (0.43%)	1
Gastrointestinal bleeding ^†	2/233 (0.86%)	2
Melena ^†	2/233 (0.86%)	2
Nausea ^†	1/233 (0.43%)	1
Oral hemorrhage ^†	1/233 (0.43%)	1
Retroperitoneal hematoma ^†	1/233 (0.43%)	1
Small bowel obstruction ^†	1/233 (0.43%)	1
Ventral hernia ^†	1/233 (0.43%)	1
General disorders
Acute chest pain ^†	1/233 (0.43%)	1
Chest pain ^†	2/233 (0.86%)	2
Delayed healing of wound ^†	3/233 (1.29%)	3
In-stent peripheral artery restenosis ^†	3/233 (1.29%)	3
Leg edema ^†	2/233 (0.86%)	2
Opiate withdrawal symptoms ^†	1/233 (0.43%)	1
Puncture site bleeding ^†	1/233 (0.43%)	1
Swelling of limb ^†	1/233 (0.43%)	1
Hepatobiliary disorders
Acute cholecystitis ^†	1/233 (0.43%)	1
Infections and infestations
Bacteremia ^†	1/233 (0.43%)	1
Bacteriuria ^†	1/233 (0.43%)	1
Cellulitis of toe ^†	1/233 (0.43%)	1
Clostridial gastroenteritis ^†	1/233 (0.43%)	1
Erysipelas ^†	1/233 (0.43%)	1
Gangrene ^†	1/233 (0.43%)	2
Gangrene peripheral ^†	3/233 (1.29%)	5
Gangrene toe ^†	5/233 (2.15%)	6
Infection of amputation stump ^†	1/233 (0.43%)	1
Osteomyelitis of the foot ^†	4/233 (1.72%)	5
Phlegmon ^†	1/233 (0.43%)	1
Pneumonia, organism unspecified ^†	4/233 (1.72%)	5
Postoperative infection ^†	1/233 (0.43%)	1
Sepsis ^†	2/233 (0.86%)	2
Soft tissue infection ^†	1/233 (0.43%)	1
Spondylodiscitis ^†	1/233 (0.43%)	2
Staphylococcus aureus bacteremia ^†	1/233 (0.43%)	1
Urinary tract infection, site not specified ^†	1/233 (0.43%)	1
Vascular access site infection ^†	1/233 (0.43%)	1
Wet gangrene ^†	1/233 (0.43%)	1
Injury, poisoning and procedural complications
Abdominal wall wound ^†	1/233 (0.43%)	1
Chronic subdural hematoma ^†	1/233 (0.43%)	1
Femoral artery pseudoaneurysm ^†	1/233 (0.43%)	1
Fracture femur ^†	1/233 (0.43%)	1
Fracture of neck of femur ^†	1/233 (0.43%)	1
Overdose NOS ^†	1/233 (0.43%)	1
Peripheral arterial reocclusion ^†	8/233 (3.43%)	10
Peripheral artery restenosis ^†	9/233 (3.86%)	10
Post procedural bleeding ^†	1/233 (0.43%)	1
Post procedural complication ^†	4/233 (1.72%)	4
Post procedural hematoma ^†	3/233 (1.29%)	3
Pseudoaneurysm ^†	5/233 (2.15%)	5
Skin tear ^†	1/233 (0.43%)	1
Traumatic brain injury ^†	1/233 (0.43%)	1
Vascular access site bleeding ^†	1/233 (0.43%)	1
Vascular access site hematoma ^†	2/233 (0.86%)	2
Wound ^†	3/233 (1.29%)	4
Wound bleeding ^†	1/233 (0.43%)	1
Metabolism and nutrition disorders
Gout aggravated ^†	1/233 (0.43%)	1
Hyperglycemia ^†	3/233 (1.29%)	3
Hyperkalemia ^†	1/233 (0.43%)	1
Hypokalemia ^†	1/233 (0.43%)	1
Hyponatremia ^†	1/233 (0.43%)	4
Type II diabetes mellitus inadequate control ^†	1/233 (0.43%)	1
Musculoskeletal and connective tissue disorders
Coxarthrosis ^†	1/233 (0.43%)	1
Hyperuricemic arthritis ^†	1/233 (0.43%)	1
Leg pain ^†	2/233 (0.86%)	2
Pain of lower extremities ^†	1/233 (0.43%)	1
Polyarthritis ^†	1/233 (0.43%)	1
Prepatellar bursitis ^†	1/233 (0.43%)	1
Soft tissue disorder ^†	1/233 (0.43%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basalioma ^†	1/233 (0.43%)	1
Diffuse large B-cell lymphoma recurrent ^†	1/233 (0.43%)	1
Leukemia ^†	1/233 (0.43%)	2
Liver carcinoma ^†	1/233 (0.43%)	1
Ovarian granulosa cell tumor ^†	1/233 (0.43%)	1
Nervous system disorders
Ataxia ^†	1/233 (0.43%)	1
Bleeding intracranial ^†	1/233 (0.43%)	1
Carotid artery stenosis ^†	2/233 (0.86%)	2
Dizziness ^†	1/233 (0.43%)	1
Drop attacks ^†	1/233 (0.43%)	1
Focal epilepsy ^†	1/233 (0.43%)	1
Stroke ^†	2/233 (0.86%)	2
Syncopal attack ^†	1/233 (0.43%)	1
TIA ^†	1/233 (0.43%)	1
Transient ischemic attack ^†	1/233 (0.43%)	1
Psychiatric disorders
Confusion ^†	1/233 (0.43%)	1
Hyperactive delirium ^†	1/233 (0.43%)	1
Transient psychosis ^†	1/233 (0.43%)	1
Renal and urinary disorders
Acute kidney injury ^†	3/233 (1.29%)	3
Acute on chronic renal failure ^†	2/233 (0.86%)	2
Acute renal failure ^†	4/233 (1.72%)	4
Renal failure ^†	1/233 (0.43%)	1
Metrorrhagia ^†	1/233 (0.43%)	1
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure ^†	1/233 (0.43%)	1
Bilateral pleural effusion ^†	2/233 (0.86%)	2
Dyspnea ^†	1/233 (0.43%)	1
Hypoxia ^†	1/233 (0.43%)	1
Lung edema ^†	1/233 (0.43%)	1
Shortness of breath ^†	1/233 (0.43%)	1
Skin and subcutaneous tissue disorders
Chronic leg ulcer ^†	1/233 (0.43%)	1
Diabetic foot ^†	1/233 (0.43%)	2
Digital ulcer ^†	2/233 (0.86%)	2
Rash ^†	1/233 (0.43%)	1
Ulcer foot ^†	1/233 (0.43%)	1
Venous ulceration ^†	1/233 (0.43%)	1
Surgical and medical procedures
Medical device battery replacement ^†	1/233 (0.43%)	1
Peripheral arterial occlusive disease Fontaine stage IV ^†	1/233 (0.43%)	1
Vascular disorders
Abdominal aortic aneurysm ^†	1/233 (0.43%)	1
Acute limb ischemia ^†	2/233 (0.86%)	2
Anterior tibial artery perforation ^†	1/233 (0.43%)	1
Arterial occlusion ^†	1/233 (0.43%)	1
Arterial spasm ^†	1/233 (0.43%)	1
Arterial stenosis ^†	2/233 (0.86%)	2
Arteriovenous fistula ^†	1/233 (0.43%)	1
Artery dissection ^†	1/233 (0.43%)	1
Atherosclerosis of arteries of the extremities ^†	1/233 (0.43%)	1
Claudication ^†	8/233 (3.43%)	10
Critical limb ischemia ^†	3/233 (1.29%)	3
Deep vein thrombosis leg ^†	1/233 (0.43%)	1
Digital necrosis ^†	3/233 (1.29%)	3
Dry gangrene foot ^†	1/233 (0.43%)	2
Dry gangrene toe ^†	1/233 (0.43%)	1
Extremity necrosis ^†	1/233 (0.43%)	1
Hematoma ^†	1/233 (0.43%)	1
Hypertension ^†	1/233 (0.43%)	1
Hypotension ^†	3/233 (1.29%)	3
Iliac artery stenosis ^†	1/233 (0.43%)	1
Internal hemorrhage ^†	1/233 (0.43%)	1
Ischemic limb pain ^†	1/233 (0.43%)	1
Peripheral arterial occlusive disease ^†	1/233 (0.43%)	1
Peripheral arterial occlusive disease aggravated ^†	5/233 (2.15%)	6
Peripheral artery occlusion ^†	1/233 (0.43%)	1
Peripheral artery thrombosis ^†	1/233 (0.43%)	1
Peripheral embolism ^†	1/233 (0.43%)	1
Peripheral vascular disease ^†	9/233 (3.86%)	10
Popliteal artery occlusion ^†	1/233 (0.43%)	1
Reperfusion injury ^†	2/233 (0.86%)	2
Superficial femoral arterial stenosis ^†	1/233 (0.43%)	1
Superficial femoral artery occlusion ^†	1/233 (0.43%)	1
Thrombosis ^†	2/233 (0.86%)	2
Tibial artery occlusion ^†	1/233 (0.43%)	1
Tibial artery stenosis ^†	1/233 (0.43%)	1
Tibial artery thrombosis ^†	1/233 (0.43%)	1
Uncontrolled hypertension ^†	1/233 (0.43%)	1
Varicose vein ^†	1/233 (0.43%)	1
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

PI acknowledges that Clinical Trial is part of multi-center clinical study. Publication of multi-center data requires prior review and consent of both Sponsor and all participating sites. PI agrees that the first publication of the results of the Clinical Trial shall be made in conjunction with results from other participating sites. Provided, however, that if no multi-center publication is made within one year from database lock, then PI may publish individually.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Nicolas Aguirre
Organization:	Philips Image Guided Therapy
Phone:	(612) 297-6655
EMail:	nicolas.aguirre@philips.com

Publications:

Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009 Dec;50(6):1462-73.e1-3. doi: 10.1016/j.jvs.2009.09.044. Epub 2009 Nov 7.

Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Adams GL, Lichtenberg M, Wissgott C, Schmidt A, Tarra T, Matricardi S, Geraghty PJ. Twenty-Four Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries. J Endovasc Ther. 2022 Mar 30:15266028221083462. doi: 10.1177/15266028221083462. Online ahead of print.

Geraghty PJ, Adams GL, Schmidt A, Lichtenberg M, Wissgott C, Armstrong EJ, Hertting K; TOBA II BTK investigators. Twelve-Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries (TOBA II BTK). J Endovasc Ther. 2020 Aug;27(4):626-636. doi: 10.1177/1526602820944402.

Layout table for additonal information

Responsible Party:	Philips Clinical & Medical Affairs Global
ClinicalTrials.gov Identifier:	NCT02942966
Other Study ID Numbers:	CA 0137
First Submitted:	October 20, 2016
First Posted:	October 24, 2016
Results First Submitted:	April 2, 2021
Results First Posted:	July 28, 2021
Last Update Posted:	January 31, 2022

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